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NCT04975347
Opioid Antagonism in Individuals Ascertained Through the Partners HealthCare Biobank
Phase 1 trial testing Naloxone in Reproductive Disorders in 47 participants. Completed in 8 August 2025.
8 August 2025
Quick facts
| Lead sponsor | Stephanie B. Seminara, MD |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | other |
| Enrollment | 47 |
| Start date | 3 June 2022 |
| Primary completion | 8 August 2025 |
| Estimated completion | 8 August 2025 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Naloxone (NALOXONE) — full drug profile →
Conditions studied
- Reproductive Disorders — all drugs for Reproductive Disorders →
Sponsor
Stephanie B. Seminara, MD — full company profile →
Who can join
Adults 18 to 60, any sex, with Reproductive Disorders. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The goal of this study is to evaluate the effects of opioid antagonists on the hypothalamic-pituitary-gonadal axis in healthy subjects.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Kisspeptin a potential therapeutic target in treatment of both metabolic and reproductive dysfunction.
Sliwowska JH, Woods NE, Alzahrani AR, Paspali E, et al · · 2024 · cited 9× · PMID 38599822 · DOI 10.1111/1753-0407.13541 -
Kisspeptin Receptor Agonists and Antagonists: Strategies for Discovery and Implications for Human Health and Disease.
Chen X, Yang S, Shaw ND, Xia M. · · 2025 · cited 1× · PMID 40430029 · DOI 10.3390/ijms26104890
Verify or expand the search:
- PubMed search for NCT04975347
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Naloxone
Trials testing the same drug.
- NCT04975334 — Opioid Antagonism in Hypogonadotropic Hypogonadism · Phase 1 · completed
- NCT05886712 — Improving Access to Naloxone to Prevent Opioid Overdose Deaths (SAIA-Naloxone) · NA · active not recruiting
- NCT05490134 — RM1 Project 1 - tAN Naloxone · EARLY_PHASE1 · recruiting
- NCT05360030 — Mechanism of Analgesic Effect on Prolonged Continuous Theta Burst Stimulation · NA · completed
- NCT05142267 — Stress and Opioid Misuse Risk: The Role of Endogenous Opioid and Endocannabinoid Mechanisms · NA · recruiting
Other Stephanie B. Seminara, MD trials
Trials by the same sponsor.
- NCT06994832 — Using Visual Arrays to Support Understanding of Genetic Risk · NA · completed
- NCT04975334 — Opioid Antagonism in Hypogonadotropic Hypogonadism · Phase 1 · completed
- NCT05901467 — Recall by Genotype: Neuropeptide Stimulation · Phase 1 · terminated
- NCT05971849 — Dampening the Reproductive Axis With Continuous Kisspeptin · Phase 1 · completed
- NCT05633966 — Kisspeptin Administration Subcutaneously to Patients With Reproductive Disorders · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04975347 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Stephanie B. Seminara, MD
- Last refreshed: 18 February 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04975347.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing